Faça parte de algo maior na BD. Aqui, você nos ajudará a manter nossos altos padrões de uma perspectiva regulatória em todos os níveis, com foco nas submissões. Requer atenção aguda aos detalhes, excelentes habilidades de comunicação e uma paixão para continuar aprendendo e atualizando seu conhecimento, o que o ajudaremos a fazer com oportunidades regulares de aprendizado. Aqui, você usará seu profundo conhecimento das regulamentações e requisitos da FDA, Canadá e ISO/MDD em torno de dispositivos médicos para atingir um objetivo único: Impulsionar o mundo da saúde™. Na BD, você pode fazer a verdadeira diferença de um.
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Job Description Summary
Be part of a team that accelerates BD’s innovative medical technologies with a patient-centric mindset. As a Regulatory Specialist, you’ll drive compliance and support multiple projects, ensuring our products meet industry standards and regulatory requirements. If you have a strong understanding of EMEA regulations and excellent communication skills, apply now!Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Why join us?
A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.
Become amaker of possiblewith us!
Our vision forRegulatory Affairat BD
The Regulatory Affairs team is helping to ensure speed to market for BD’s innovative medical technologies by having an acutely patient-centric mindset.
About the role
The Regulatory Specialist is responsible for supporting and driving regulatory activities across multiple projects and product lines. This role ensures compliance with industry standards and regulatory requirements by reviewing and approving advertising and promotional materials, leading regulatory and product-related documentation, and providing local regulatory support. Additionally, the Regulatory Specialist leads special projects and collaborates closely with cross-functional teams to support business initiatives, offering subject matter expertise on EMEA legislation and standards.
Main responsibilities will include:
- Review and approve advertising and promotional materials to ensure compliance with regulatory legislations, guidelines and company standards.
- Maintain and update the Technical Documentation Repository (including Technical Data Sheet, Instructions for Use,, Declaration of Conformity, …) to ensure timely and accurate records for internal and external needs and requests..
- Address product-specific regulatory queries from local teams to support market access and compliance.
- Lead non-product-specific regulatory projects, Be responsible for label review and approval processes to ensure alignment with regional and global regulatory standards.
- Collaborate with European distribution center quality teams to provide regulatory input on CRAF procedures and processes
- Provide support to BU willing to engage in partnerships and joint initiatives, OEM management.
- Support regional initiatives for CE marking and other regulatory asks, ensuring products meet all requirements for European market access.
- Serve as a subject matter authority on EU regulations, offering mentorship to internal teams on regulatory standards and compliance issues.
About you
- Bachelor’s degreein Life Sciences or related field (Master’s preferred).
- 3-5 yearsin regulatory affairs, preferably in medical devices or pharmaceuticals.
- Strong understanding of EMEA legislation, standards, and regulatory frameworks, particularly for medical devices, including IVDs, and non-medical products.
- Ability to lead and manage special projects across regulatory and cross-functional teams.
- Proficiency in managing regulatory documentation.
- Excellent interpersonal skills for both technical and non-technical teams.
Click on apply if this sounds like you!
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
To learn more about BD visit:https://bd.com/careers
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Primary Work Location
BEL Erembodegem - Dorp 86Additional Locations
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Perfil de Sucesso
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Analítico
- Colaborativo
- Comunicador
- Persuasivo
- Solucionador de problemas
- Apresentador habilidoso
Impulsionando o mundo da saúde™
BD é uma das maiores empresas globais de tecnologia médica do mundo e está Impulsionando o mundo da saúde™ melhorando a descoberta médica, o diagnóstico e a entrega de cuidado. A BD ajuda os clientes a melhorar os resultados, reduzir custos, aumentar a eficiência, melhorar a segurança e expandir o acesso aos cuidados de saúde.